Effective Interventions to Overcome Severe Gag Reflex
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anesthetic spray, Acupuncture, Masking Tape.
- Who it may be relevant to
- Registry conditions: Gagging. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to evaluate the use of various techniques in alleviating gag reflex following gag reflex stimulation. Primary aim: To compare if there is any reduction in gag reflex from each of the following interventions * Acupuncture (CV-24) * Tape * Anesthetic spray Secondary aim: to compare the degree of gag reduction
Detailed description
The purpose of this study is to evaluate the use of various techniques in alleviating gag reflex following gag reflex stimulation.
Primary aim: To compare if there is any reduction in gag reflex from each of the following interventions
* Acupuncture (CV-24) * Tape * Anesthetic spray Secondary aim: to compare the degree of gag reduction
Interventions
- Drug Anesthetic spray
will be applied to back of the throat for 10 seconds; their chin will also be concealed from the GSI examiner using a small cup and masking tape. - Device Acupuncture
A 6C file (endodontic instrumentation file) will be placed on the patient's mentolabial fold (CV24). This file will be concealed by a small paper cup; A clean alcohol wipe will be used to clean the mentolabial area prior to placing the "acupuncture needle" (6 C-File). - Genetic Masking Tape
A piece of commercially available masking tape will be adhered to the patient's mentolabial fold and concealed by the small paper cup
Primary outcome measures
- Change in Gag Reflex Severity Index (GSI) Score From Pre- to Post-Intervention [Time frame: 90 minutes per subject]
Secondary outcome measures (1)
- Self-Reported Degree of Gag Reflex Reduction Using Visual Analog Scale (VAS) [Time frame: Immediately post-intervention during single study visit]
Eligibility criteria
Inclusion criteria
- 18 years or older (individuals below 18 years will be excluded from the study as the study procedures might not be well tolerated by them, and they are not the primary population on which these procedures are used).
- Students, faculty, or staff of Tufts SDM
- Subjects who score a 2 or higher on the Gagging Severity Index (GSI)7 and have a positive gag reflex response when stimulated with a cotton swab at the base of the tongue/uvula/tonsil region.
Exclusion criteria
- Adults unable to consent (cognitively impaired adults)
- Wards of the state
- Pregnant women (those that are self-reported)
- Current use of anticoagulants
- Allergy to xylocaine
- Those with bleeding disorders
- Those who participated in the Calibration phase of this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Tufts University School of Dental Medicine — Boston
Identifiers
NCT: NCT07099131 · 6213